JO,
here is very good news on NXCO:
Tuesday March 31, 6:56 am Eastern Time
Company Press Release
Neurex Completes Ziconotide Phase III Malignant Pain Trial
Preliminary Results Support NDA Filing
MENLO PARK, Calif.--(BW HealthWire)--March 31, 1998-- Neurex Corporation (Nasdaq: NXCO - news) announced today that it completed patient enrollment in its Phase III trial of ziconotide (SNX-111) in patients with chronic malignant pain caused by cancer or AIDS.
The trial, originally planned to enroll 165 evaluable patients, was terminated after 111 patients were randomized. The Company believes that this will be sufficient to achieve statistical significance and, therefore, serve as the second pivotal trial in the ziconotide NDA. The preliminary blinded analysis was performed by a third party to determine the difference in pain reduction between the ziconotide and placebo groups. This analysis indicated a substantial difference between the two groups with a 52% reduction in one group compared to only 27% in the other. Based on this analysis, this difference in pain relief between groups is clearly clinically and statistically significant.
''We are extremely pleased with the substantial difference in pain relief between the two groups. It appears that ziconotide is having a dramatic effect in patients with severe intractable pain and who have failed or become intolerant to morphine therapy,'' said Robert R. Luther, M.D., Executive Vice President. ''We look forward to filing the ziconotide NDA and to working closely with FDA to expedite approval to market this exciting new analgesic product.''
The Company believes that the preliminary results of the pivotal malignant pain trial, coupled with the similarly impressive results from the interim analysis of the completed pivotal Phase III trial in patients with chronic neuropathic pain, support an NDA filing. The neuropathic pain trial enrolled a total of approximately 260 patients by year-end 1997. Interim data from the first 102 patients in the neuropathic pain trial were released on January 13, 1998. Those data indicated that the difference in the primary end point of pain reduction between the treated and placebo groups was so robust that significance could have been demonstrated in approximately 60 evaluable patients.
''We are pleased to bring the malignant pain trial to an early close, and that we are able to assemble the NDA with two completed pivotal studies,'' said Paul Goddard, Ph.D., Chairman and CEO. He added, ''We continue to believe that ziconotide possesses a profile which has the potential to bring dramatic pain relief to a large population of patients for whom no adequate therapy currently exists.''
Neurex Corporation is developing products for acute care, principally in the area of cardiorenal and neurological disease. CORLOPAM(R) (fenoldopam mesylate) was launched commercially in January 1998. Enrollment targets for the ziconotide Phase III trials for head trauma are currently underway. Both Corlopam and ziconotide have potential in multiple indications. The Company's strategy is to discover, develop and commercialize its products for acute care treatment in hospital settings, such as emergency rooms, intensive care units and pain clinics.
Note: This news release contains forward-looking statements that involve risks and uncertainties, including without limitation to risks associated with clinical development, regulatory approvals, and other risks and uncertainties described from time to time in the SEC reports filed by Neurex, including the most recently filed Forms 10-Q and 10-K.
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